I believe that the veterinary medicine revision is absolutely essential in remedying the failings of the current EU regulations, especially regarding issues such as the availability of drugs, reducing red tape and combating antibiotic resistance.
In my report, I wanted to stress three areas of action which I think are crucial. First, the processes aimed at better tackling antibiotic resistance. The European Commission has made a number of proposals on this issue but I believe that we need to go much further.
I have called for an end to the routine prophylactic use of antibiotics and have asked for clarification on article 107 on the prescription and sale of veterinary medicines.
I also want to encourage research in the field of antibiotic therapy, and also to introduce the concept of 'reciprocity', so that the antimicrobial standards which we apply here in Europe are also applied to imported meat and products originating from livestock from outside the EU.
We need measures aimed at encouraging research and innovation, particularly on extending data protection periods, without which we cannot hope to improve the availability of veterinary medicinal products.
And regarding the issue of pharmacovigilance, we need to reconsider the Commission's latest approach which is solely risk-based.
A hybrid system based at first on the regular submission of pharmacovigilance reports during the product's first years, followed by risk and safety analysis seems more suitable to me for protecting public health.
The Commission has also proposed in its draft that certain antibiotics, of critical importance, be reserved for human medicine. That is a proposal which I support.
However, we need to define the criteria which will be used to establish such a list. The Commission plans to define this list through the use of delegated acts and not within the body of the text, which in my view is a good solution, as it should be established on a solid scientific basis and not after a political debate.
I have asked the Commission to base the list on the European Medicines Agency's recommendations, in particular the agency's answers to the Commission's questions on that subject, published last December.
The online sale of veterinary drugs is another important issue in the new regulation that has generated major concerns, especially within the context of unnecessary antibiotics use.
I entirely share those fears concerning the online sale of antibiotics and veterinary medicines available only on prescription.
Online sales make fraud and illegal counterfeiting easier while making it harder to trace these products, something which is crucial when it comes to antibiotic use.
The Commission proposed creating a number of safeguards against this, including a European label identifying 'safe' online sites. However, I don't think that is enough, quite simply because I think it is impossible to carry out effective checks.
My position therefore is clear. I want to ban the online sale of prescription veterinary medicinal products or, at the very least, the online sale of antibiotic drugs.
This is one of the red lines of my report and I am determined to have that position adopted. I believe I can count on cross-party support from my MEP colleagues on this.
I also want to introduce bolder measures regarding protection of the environment, which were generally thought to be inadequately covered by the Commission's proposal.
The current system evaluates how dangerous substances present in veterinary medicinal products are. Instead, I have asked the Commission to assess the opportunity of introducing concrete proposals within two years to implement an environmental monograph system.
Under the new system, impact assessments should be carried out by substance as opposed to product. I believe that going forward, it would be a good idea to assess the viability of such a system.
I realise the veterinary medicinal product market will not change overnight, and that the new regulation will not solve all the problems, particularly regarding antimicrobial resistance.
I will have to make concessions to my colleagues so that these measures can be quickly adopted. Yet I firmly believe the major changes introduced in this legislation will create a safer, stronger and more appealing market, of the greatest benefit to animal welfare and human health.